Building community partnerships: case studies of ... - SAGE Journals

Clinical Trials 2008; 5: 147–156

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Building community partnerships: case studies of Community Advisory Boards at research sites in Peru, Zimbabwe, and Thailand Stephen F Morina, Simon Morfita, Andre Maioranaa, Apinun Aramrattanab, Pedro Goicocheac, John Michael Mutsambi d, Jonathan Leserman Robbinsb and T Anne Richardsa Background Differences in resources, knowledge, and infrastructure between countries initiating and countries hosting HIV prevention research trials frequently yield ethical dilemmas. Community Advisory Boards (CABs) have emerged as one strategy for establishing partnerships between researchers and host communities to promote community consultation in socially sensitive research. Purpose To understand the evolution of CABs and community partnerships at international research sites conducting HIV prevention trials. Methods Three research sites of the HIV Prevention Trials Network (HPTN) were selected to include geographical representation and diverse populations at risk for HIV/AIDS – in Lima, Peru; Chitungwiza, Zimbabwe; and Chiang Mai, Thailand. Data collection included review of secondary data, including academic publications and site-specific progress reports; observations at the research sites; face-to-face interviews with CAB members, research staff, and other key informants; and focus groups with study participants. Rapid assessment techniques were used for data analysis. Results Two of the three CABs developed new strategies for community representation in response to new studies. All three CABs expanded their original function and became advocates for broader community interests beyond HIV prevention. The participation and input of community representatives, in response to critical incidents that occurred at the sites over the past five years, helped to solidify partnerships between researchers and communities. Limitations Rapid Assessment is an exploratory methodology designed to provide an understanding of a situation based on the integration of multiple data sources, collected within a short period of time, without a formal examination of transcribed and coded data. Case studies, as a method, are meant to draw out what can be learned from a single case but are not, in the scientific sense, generalizable. Conclusions In developing countries, CABs can be dynamic entities that enhance the HIV research process, assist in responding to issues involving research ethics, and prepare communities for HIV research. Clinical Trials 2008; 5: 147–156. http://ctj.sagepub.com

Background Research in developing countries presents distinct opportunities and challenges. The kind of

complicated trials often associated with HIV/AIDS research in these regions cannot succeed without the support and cooperation of the host country and affected communities. Yet, recent controversies

a Center for AIDS Prevention Studies, University of California, San Francisco, bResearch Institute for Health Sciences, Chiang Mai University, Thailand, cAsociacio´n Civil Impacta Salud y Educacio´n, Lima, dUniversity of Zimbabwe, Harare Author for correspondence: Stephen F Morin, Center for AIDS Prevention Studies, University of California, San Francisco, 50 Beale Street, Suite 1300, San Francisco, CA 95105. E-mail: [email protected]

ß Society for Clinical Trials 2008 SAGE Publications, Los Angeles, London, New Delhi and Singapore

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regarding clinical trials conducted in developing countries indicate that much remains to be learned about what constitutes effective community collaboration [1–5]. Trials in developing countries have been halted or suspended for a variety of reasons, including lack of consensus on ethical issues, lack of appropriate care and treatment of participants, and lack of adequate community consultation. Developing countries are hardest hit by the HIV epidemic and are increasingly the site of prevention research trials. Differences in resources, knowledge, and infrastructure between countries initiating and countries hosting the research frequently yield ethical dilemmas. Establishing partnerships between researchers and host communities has evolved as a recommended means to navigate these challenges by identifying and addressing ethical concerns to assist the successful implementation of research. Ideally, a collaborative relationship is formed between researchers and relevant host country representatives in all aspects of research, including study design, implementation, and conclusion. Community Advisory Boards (CABs) have emerged as one strategy for establishing partnerships that promote community consultation in socially sensitive research [6]. Originating in the initial HIV treatment studies taking place in the United States [6–10], CABs serve as a voice for the community and study participants. Researchcommunity collaboration and CAB development have been identified as important issues in public health and specifically in HIV research [11–15]. The structure and function of CABs varies according to the local context and situation [16–18]. The HIV Prevention Trials Network (HPTN), established in 1999 by the National Institute of Allergy and Infectious Diseases (NIAID), is a collaborative of 26 international research sites. The Network’s primary aim is to evaluate the safety and efficacy of nonvaccine HIV prevention interventions. Central to these goals is the principle of collaboration and partnerships between researchers and the host community in research design, implementation, dissemination of results, establishment of future research agendas, and administrative operation. Each site is required to establish, support, and maintain community participation through a CAB. These activities are facilitated by the HPTN’s Community Working Group (CWG), the administrative body responsible for promoting the inclusion of the community as partners in HPTN research [19]. While the HPTN has been reconfigured beginning in 2006, the Community Working Group has been maintained and similar community programs have been incorporated into other research networks as well. Clinical Trials 2008; 5: 147–156

Purpose In 2001, we conducted case studies at three international HPTN sites: Lima, Peru; Chitungwiza, Zimbabwe; and Chiang Mai, Thailand; as well as at three domestic sites: Philadelphia, Pennsylvania; Birmingham, Alabama; and Los Angeles, California, to better understand how CABs are used to improve HIV clinical trials [20]. At that time, the community advisory structures at the international sites were in early stages of development. The issues we encountered revolved around the determination of roles, responsibilities, and effective communication strategies in community partnerships. The findings from this earlier study have been used by HPTN to develop monitoring and evaluation measures for community participation and to train CABs at local sites. Our goal in the current study was to better understand how CABs have matured over the last five years at the three international research sites from the prior study, and to explore and understand how partnerships have evolved between community representatives and researchers.

Methods Case studies The three sites selected (Lima, Chitungwiza, and Chiang Mai) reflect different geographic regions (South America, Africa, and Asia), as well as the diversity in populations at risk and primary research focus (behavioral, microbicides, sexually transmitted disease, antiretroviral drugs, injection drug use, and mother-to-child transmission) represented in the HPTN. We contacted the principal investigators at each research site to seek the site’s participation in the study, and all sites agreed to be involved. The University of California, San Francisco (UCSF) Institutional Review Board (IRB) approved the study protocol, as did ethics committees at each of the international sites.

Data collection As with our 2001 project, we used a rapid assessment model of data collection [21]. This type of qualitative inquiry was especially suited to our research questions because our study focused on the process of CAB development and the interaction among CAB members, research team members, and trial participants. Understanding the process by which events and actions take place is a hallmark of qualitative research [22]. http://ctj.sagepub.com

Building community and research partnerships Rapid assessment uses a multi-disciplinary team to develop a qualitative understanding of a situation [21]. The disciplines represented in the three-member UCSF research field team include anthropology, psychology, and public health. The diversity in perspectives ensures a more comprehensive understanding of researchcommunity partnerships. In keeping with the rapid assessment approach, the same field team (Richards, Morfit, & Maiorana) visited each research unit for seven consecutive days between February and May, 2006. Richards served as the senior analyst. Four sources of data were collected. First, prior to fieldwork, we gathered secondary data on community-based research (HPTN site reports, academic journals, the press, publications from development organizations, and nongovernmental organizations [NGOs]); HIV/AIDS epidemiological data for each country; reports on recent political and economic histories; and the findings from our 2001 study. These secondary data were used as background information for our study. Second, we conducted 36 face-to-face semistructured interviews with a purposeful sample of CAB and research team members selected on the recommendation of local staff as individuals who would best be able to describe the evolution of community partnerships at each of the sites over recent years. Third, we conducted three focus groups, one at each site, with a total of 27 individuals participating in HPTN clinical trials. Finally, we held 16 informal interviews with key informants: Community Working Group Program Managers, who provide support to community members and research staff, members of NGOs, faith-based organizations, and non-HPTN research staff. The sampling strategy was designed to select ‘information rich’ [23] participants with different roles and direct experience on the community consultation process. The sample size was consistent with qualitative methods and the purpose of the study, which involved assessing the views of a relatively small group of people – namely, members of research teams, members of CABs, and clinical trial participants [23,24]. We had regular communications with each site through conference calls, e-mails, and in-person discussions. These discussions determined criteria for participation in the interviews and focus groups. At each site, research team members closely linked to the field assisted us in identifying participants to be interviewed. Such a recruitment strategy is often necessary when researchers are unable to identify or have difficulty accessing appropriate informants due to remote research locations and time limitations [25]. http://ctj.sagepub.com

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After being presented with the study, CAB members in Peru and Thailand self selected to participate in the interviews. The Zimbabwe CAB interviewees were identified through communications with the Community Liaison Director. Peru and Thailand recruited focus group participants through the use of a flyer. We sampled research staff members at various levels within the organizational structure – from the site director, and principal investigators, to outreach and recruitment staff (Table 1). One of the UCSF field staff conducted each of the interviews and focus groups. Interviews and focus groups were conducted in Spanish, Shona, and Thai when necessary. When translation services were required, an interpreter was used. Written informed consent was obtained prior to interviews. Interviews and focus groups lasted between 60 and 120 min. Participants were paid for their time in local currency in keeping with in-country standards of research trial compensation. With the permission of the participant, all discussions were audio taped with the exception of focus groups and informal interviews, which were documented through hand-written notes.

Interview guides Interview and focus group participants were asked to describe the following: how the clinical trials research process has changed with time; how community involvement could be enhanced; the history and context of HIV, HIV services, and HIV research; the process of collaboration and interaction among researchers, CABs, and the larger community; and the broader impact of the research. CAB members and research staff were asked to elaborate on ethical issues that arose during the conduct of research. Focus group participants were asked to describe their experience in clinical trials and their motivation for participating. No interview guides were used to structure informal interviews; instead, discussions explored the relationship among the research structure, government offices, and civil society organizations. Table 1 Summary of type and number of interview and focus group participants across sites

Research staff CAB members Focus group with study participants Informal interviews

Zimbabwe

Thailand

Peru

6 6 10

6 8 10

4 6 7

5

8

3


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Data analysis Rapid assessment is an iterative process of data collection, data review, and analysis [21]. Triangulation of data, or using multiple sources of data, is an important component of rapid assessment techniques [26]. Following each interview, the interviewer reviewed the audio recording, noting important themes. At the end of each day of data collection the research team met to review, discuss and integrate their respective notes. A consensus approach was used to capture and distill the themes and concepts emerging from the interview discussion. The notes formed the basis for analyses and report writing. The thematic classifications were based on a priori issues identified through the secondary data and emergent themes arising during the data collection and analysis processes. The initial thematic classifications were applied and compared to subsequently collected data and were then refined to capture concepts not previously integrated. This process of analysis and modification assisted with making the conclusions and recommendations comprehensive. Meetings were held at the end of each of the visits with site staff to verify and share the results of the study. In-depth analyses of transcribed interviews are not presented in this article.

Results Peru The Lima site was formed in 2000 in collaboration with the University of Washington to conduct HPTN-sponsored HIV and sexually transmitted infection research with an emphasis on men who have sex with men [19]. Over time the research agenda expanded to include non-HPTN studies. The two HPTN studies taking place in Lima examine the prevalence of HIV and HSV-2, and treating HSV-2 as a prevention intervention, while the 12 non-HPTN studies explore a range of issues including vaccines, sexual risk behavior, and voluntary counseling and testing. See Table 2 for a list of HPTN studies at the three sites. The existence of a well-defined Community Education and Involvement Department within the research structure provides the interface with study participants, the CAB, and the community at large. This department served multiple functions. Research staff conduct formative research to identify community needs and map social venues in different areas of Lima to facilitate study recruitment and retention activities. They also organize Clinical Trials 2008; 5: 147–156

large-scale community events to present studies and discuss results. The Recruitment and Retention Unit within the Department uses peer educators and promoters as another means of direct community engagement with current and potential study participants. The site further offers nonresearchrelated clinic services, where clients can receive free sexual health care or participate in social and community building activities. Periodically, evaluations are conducted to assess the quality of delivery of research and care services. When the site was established in 2000, the CAB was a new concept of community engagement strongly promoted by HPTN. When the CAB was organized, research staff invited representatives from NGOs dealing with HIV, Ministry of Health staff, members of the gay movement in Lima, people living with HIV/AIDS, men who have sex with men, and female sex workers. At first, since the CAB structure was a new concept in Peru, CAB functions were not clear. This was exacerbated by a lack of research protocols to review. As one researcher stated, ‘The CAB would convene but not know what to do.’ While waiting for protocols, research staff collaborated with CAB members in developing free clinical care programs for men who have sex with men and social activities for community building. By 2002 CAB membership declined from 13 to 7 members due to role ambiguity. In 2002, CAB members began to question the difference between the CAB and the local IRB. Problems arose when the CAB was given protocols already approved by the IRB. One researcher overseeing CAB development reported CAB members asking, ‘If we can’t stop the protocols, what’s the point?’ Between 2002 and 2004 the CAB came to realize that although they could not determine which protocols were to be implemented, they had the power to go to their respective communities and tell people not to participate in the trials. Ultimately, researchers at the site agreed that the CAB would review protocols prior to submitting them to the IRB. In 2005, the selection of the Lima site for a pre-exposure prophylaxis trial was a stimulus for growth for the CAB. The use of daily anti-retroviral drugs for prevention of HIV infection rather than treatment had been controversial at other international sites. The proposed study was controversial in Lima as well. CAB members reported being pressured by NGOs concerned with the ethics of the study. CAB members themselves raised ethical questions about this project. According to one researcher, the CAB wanted to know ‘if clinical trials should be answering to the necessities of the communities why are we doing trials that do not apply to the http://ctj.sagepub.com

Building community and research partnerships Table 2

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HPTN and non-HPTN studies across sites

Site

Full HPTN study name

Number non-HPTN studies

Non-HPTN study content

Chitungwiza, Zimbabwe

(1) HPTN 035: Phase II/IIb Safety and Effectiveness Study of the Vaginal Microbicides BufferGel and 0.5% PRO2000/5 Gel (P) for the Prevention of HIV Infection in Women. (2) HPTN 046: Phase III Trial to Determine the Efficacy and Safety of an Extended Regimen of Nevirapine in Infants Born to HIV Infected Women to Prevent Vertical HIV Transmission During Breastfeeding. (3) HPTN 052: A Randomized Trial to Evaluate the Effectiveness of Antiretroviral Therapy Plus HIV Primary Care versus HIV Primary Care Alone to Prevent the Sexual Transmission of HIV-1 in Serodiscordant Couples. (4) HPTN 039: A Phase III, Randomized, Double-Blind, Placebo-controlled Trial of Acyclovir for the Reduction of HIV Acquisition among High Risk HSV-2 Seropositive, HIVSeronegative Individuals. (5) HPTN 043: NIMH Project Accept: A Phase III Randomized Controlled Trial of Community Mobilization, Mobile Testing, Same-Day Results, and Post-Test Support for HIV in SubSaharan Africa and Thailand. (1) HPTN 037: A Phase III Randomized Study to Evaluate the Efficacy of a Network-oriented Peer Educator Intervention for the Prevention of HIV Transmission Among Injection Drug Users And Their Network Members (2) HPTN 058: A Phase III Randomized Controlled Trial to Evaluate the Efficacy of Buprenorphine/Naloxone Drug Treatment in Prevention of HIV Infection among Opiate Dependent Injectors. (3) HPTN 052: A Randomized Trial to Evaluate the Effectiveness of Antiretroviral Therapy Plus HIV Primary Care versus HIV Primary Care Alone to Prevent the Sexual Transmission of HIV-1 in Serodiscordant Couples. (4) HPTN 043: NIMH Project Accept: A Phase III Randomized Controlled Trial of Community Mobilization, Mobile Testing, Same-Day Results, and Post-Test Support for HIV in SubSaharan Africa and Thailand. (1) HPTN 036: HIV Prevalence, Incidence, and HSV-2 Prevalence Among High-Risk MSM in Peru´. (2) HPTN 039: HPTN 039: A Phase III, Randomized, DoubleBlind, Placebo-controlled Trial of Acyclovir for the Reduction of HIV Acquisition among High Risk HSV-2 Seropositive, HIVSeronegative Individuals.

10

-Microbicides -Youth Micro-credit -Diaphragm and HIV Prevention -HIV Vaccines - Adult AIDS Clinical Trials Group

9

-Methamphetamine -HIV Vaccines -Adult AIDS Clinical Trials Group -Pediatric Clinical Trials

12

-VCT among CSW and Clients -HSV and HIV -Sentinel Surveillance in the Andes -Acyclovir HSV treatment, HAART and HIV -Adolescent STI/HIV surveillance in Latin America and the Caribbean -Recent HIV infection in Lima MSM Screening HIV Positive Lima women -Ethnography of Condom Use -HIV Vaccines -HLA antigen typing and etiopes mapping

Chiang Mai, Thailand

Lima, Peru

necessities of the community? We don’t have Tenofovir for people living with HIV here. . . . Why aren’t we putting money into Tenofovir for people living with HIV?’ The controversy over the pre-exposure prophylaxis trial was in part a reason for expanding the http://ctj.sagepub.com

composition of the Peru CAB. While the situation was complex, one argument made by some community members was that the CAB was not sufficiently representative of potential trial participants and not sufficiently independent of the research organization. In response, the research Clinical Trials 2008; 5: 147–156

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site expanded the membership from 7 to 16 by including former study participants and participants from the community mobilization activities organized by the research site. The newly expanded CAB took two months to review the proposed protocol and make suggestions, which were incorporated into the trial design. In Peru, sexual minorities have experienced stigma, homophobia, and social prejudice in accessing health care. Research and CAB interviewees as well as focus group participants described experiences of hostile and poor quality care, even outright refusal of care. In addition to its research studies, the site in Lima offers nonresearch-related clinic services; clients can receive free sexual health care. All interview and focus group participants described the delivery of care and services as respectful, thorough, efficient, and compassionate. Consequently, the site is a preferred option for health care among men who have sex with men. Peru CAB and focus group participants indicated that there is currently less fear surrounding HIV due to an increase in education. As a CAB member stated: ‘Now people are not so afraid of learning that they are HIV positive, they know that this is not the end.’ Focus groups participants also felt trial participation bolstered their sense of responsibility about their own health, sexual behavior, and life in general.

Zimbabwe In 1996, Zimbabwe became a National Institutes of Health-funded research site, implementing a condom promotion and counseling study for women attending postnatal and family planning clinics. With the entry of HPTN in 1999 the number of research projects has increased. The Zimbabwe site has housed 15 research studies, 5 of which are HPTN studies, investigating a range of topics such as microbicides, HSV-2 suppression, mother-to- child HIV transmission and diaphragm use in HIV prevention. The relationship between research and community has been greatly facilitated through the work of the Community Liaison Department, where staff oversee the interface of research with the CAB and the community at large. The Director and staff of the Community Liaison Department have backgrounds in cultural anthropology, social work, and health education that equip them to respond to issues that may arise in the implementation of research. The Department ensures that appropriate constituencies are represented in the CAB, educates CAB members about CAB functions, delivers protocol-related trainings, and fosters active CAB


participation in the research process. Staff also monitor the interaction of research projects directly with the community through outreach activities and attend community meetings to understand community concerns. The Zimbabwe site relies on multiple referral sources, including outreach workers and community member recommendations for identifying and recruiting CAB members. These referrals are then verified by the Community Liaison Department to ensure a good fit with CAB membership requirements. Beginning in 2000, the Zimbabwe site formed one CAB with 14 members based in Chitungwiza, a former township outside of Harare [19]. Two other CABs were formed in 2001 in Epworth and Harare to represent these respective communities in the research process. CAB representation is broad-based, with members drawn from local government offices, hospital administrators, religious leaders, police, and NGOs. Because Chitungwiza was the site for our prior study, we focused on this CAB in our current study. Since 2001, the CAB has achieved greater clarity in terms of their place within the research structure and their community. Five years ago members were trying to determine if they were responsible to the researchers, the community or local authorities. Five years later the CAB articulated their accountability to the community. As one CAB member noted, ‘the community is on top, then the CAB, then researchers.’ At the same time, CAB members expressed an understanding of the necessity of engaging the hierarchical tiers of Zimbabwe society with all levels working together. CAB members understood the consultation process that starts with national level authorities, and the Ministry of Health, followed by the local municipalities. The responsibilities of the CAB have evolved beyond the intermediary role between research and community. For instance, the CAB functioned as a mediator between the research and the larger community to navigate the political climate and offered guidance on how to respond to national political events, recognizing the importance of remaining ‘apolitical.’ The CAB was instrumental in helping researchers respond to the government’s Operation Clean Up, the demolition of informal housing and commercial venues, which displaced many research participants. The CAB helped identify and implement methods to locate lost participants after the forced relocation, achieving a 99% participant retention rate [27]. The mission and goals of the CAB are evolving. Interviewees described a new vision of broader CAB function: a holistic approach to HIV/AIDS encompassing the social factors surrounding the disease, such as alcohol abuse; training CABs in other

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Building community and research partnerships communities; and research partnered with community development, such as micro-finance, hygiene, housing, and orphan care. The CAB is already taking steps in this direction. Most notably, when confronted with a recent cholera outbreak, the networks of communication and mobilization developed and maintained through the CAB were harnessed to promote cholera prevention. After more than 5 years, the conduct of internationally sponsored HIV-related research has had a substantial effect in the Harare area. It was the consensus of research staff, CAB members, and community members that the presence of research and the establishment of community partnerships via the CABs were a factor in increasing HIV knowledge, awareness, and testing. Increased HIV awareness and understanding has led to more open discussion of HIV/AIDS and related issues within group settings, such as clinics and hospitals, churches, youth street theatre, and open forums. The majority of research being conducted at this site is targeted towards women. Women speak with friends and acquaintances about their participation in the studies. The topics of sexual risk and HIV testing, previously unspoken between men and women, are now being discussed. Increasingly, men will come in for testing after their spouse or partner has done so. As a research staff member said, ‘A dialogue [that] was not there is now taking place. It is now a public thing not a secret.’ However, a disparity still exists in HIV knowledge and access to care between women and their partners. There is growing sentiment that this difference needs to be reconciled to improve the success of prevention.

Thailand Internationally sponsored HIV research began in Chiang Mai in 1999 when the Research Institute for Health Sciences partnered with both the prevention and vaccine trials networks [19]. In carrying out HIV prevention research the site collaborates with Johns Hopkins University. The Chiang Mai site has conducted thirteen studies (four HPTN and nine non-HPTN) dealing with substance abuse, anti-retroviral therapy, community mobilization on mobile voluntary counseling and testing, HIV vaccines, HIV-infected adults, and mother-to-child transmission. The community coordinator, a nurse and former health educator, oversees administration of the CAB and organizes the bi-monthly CAB meeting agendas. The coordinator and her assistant disseminate information on upcoming studies, trial progress and results through a monthly community radio program and a bi-monthly newsletter.


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The Chiang Mai site first developed a CAB in 1999 to facilitate a small vaccine trial. Since then, the social and political contexts have contributed to a restructuring of the community advisory mechanisms. In Thailand the government implemented a strict policy on drug use dubbed ‘the War on Drugs’ that involved harsh measures by international standards that have had a negative impact on HIV research and services. Because the site was involved in HIV prevention research with substance users, community concern was raised about risk to potential participants who were already a marginalized population and were difficult for the researchers to recruit. Given the social climate generated by the anti-drug policies, it was necessary to involve local government, police and health officials in the implementation of research and community consultation processes. The Chiang Mai CAB consists of 23 members comprised of a broad cross-section of government officials, religious leaders, local NGOs, health officials, research staff, and people living with HIV/AIDS. This group reviews all protocols and consent forms. As the site initiated prevention research involving substance-using populations, a Substance Abuse CAB was formed to improve the quality of community consultation and to better understand the perspectives and needs of this group. Among the 23 members of this population-specific group there are former users and members from injection drug user service organizations and former university staff who worked with the injection drug user population. In addition, a third strategy was established to work directly with specific geographic locations where recruitment was being planned. The establishment of population-specific and geographic-specific advisory mechanisms has helped build trust with injection drug user populations and ensures that the conduct of research is sensitive to the needs of these populations. At the time of the site visit, these advisory groups were involved with three main issues surrounding the closure of an injection drug user peer education trial due to lower than expected HIV incidence: explaining the rationale for the closure, redirecting participants to other service resources and preserving trust among study participants for future research. The community involvement strategies developed in response to research needs. The three groups do not interact with each other on a regular basis, but rather have independent interactions with the research staff. Representatives from the three advisory structures were not able to clearly articulate distinctions in each of their roles and relationships to the research and broader community.


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CAB members with the greatest understanding of their roles were individuals who had direct personal engagement with communities where research was being conducted. CAB members who did not have this direct tie to the community appeared to have less clarity about their roles, the effectiveness of the CAB and, in some cases, less of an ability to discuss details of the research protocols. As one CAB member stated, ‘how can we contribute to a trial in a new area? What is our positive contribution? . . . What is our active role besides coming in and sitting and going through documents without real connection to the community?’ Recently, the groups have taken a more active role in influencing protocol development, as opposed to commenting on a final protocol or what one research member described as ‘Too late to incorporate CAB feedback.’ In 2006, the groups participated in the development of a compassionate-use post-trial agreement with Thai investigators conducting an HPTN trial. Currently, the drug under investigation (Suboxone) is being studied to determine its efficacy in changing drug-use behaviors as a means to reduce HIV infections among injectors. The drug is not available in Thailand outside of research studies. In a series of community forums, CAB members expressed concerns about the post-study availability of the drug. After conveying their sentiments to the protocol team, the manufacturer agreed to make the drug available to a health care provider at the study location until the drug is commercially available. The CAB model is being adopted and used for other endeavors in Thailand. The community advisory structures are not used exclusively for HPTN projects and provide advice to non-HPTN research. The research site is planning to use a CAB approach in their upcoming work exploring pesticide use among farmers. Similarly, a CAB member indicated that the Thai Red Cross was interested in using such a structure in their work. The research trials in Chiang Mai are a source of counseling, information and support for injection drug users and the community in general. Focus group participants indicated that the research projects improved their lives by offering them a safe place to go and a chance to increase their knowledge of drug and health issues. In conducting its work with the injection drug user population, the Thai site offers a safe-space drop-in center where people can relax, drink coffee, have snacks and talk with others. Support groups are also offered where individuals can talk about personal issues. On the larger community level, people may be more supportive of research because of the life changes that research participation may bring to substance users. These visible changes have Clinical Trials 2008; 5: 147–156

influenced relationships between study participants and family and community members.

Discussion In 2001, international CABs were relatively new. Researchers and CAB members were struggling to define CAB identity, as well as their relationship to the research and their own communities. We found that these specific CABs have matured in significant ways and become more integrated into the research process. All three CABs were instrumental in raising ethical concerns, such as whether the research would lead to lasting benefits for the host country or whether research participants and vulnerable segments of the community would be adequately protected. All three promoted more open discussion of HIV/AIDS within their communities, which may contribute to diminishing stigma and promoting acceptance of the research. Finally, all three have developed a sense that they are advocates for the interests and concerns of the people they represent. We found that certain ‘critical incidents’ seem to be important turning points in the maturation of these entities. At each site, a conflict or challenge arose in which the views and assistance of CAB members became especially valuable to the team and the future success of the research. These obstacles, resulting from a particular research trial (e.g., a controversial pre-exposure prophylaxis trial in Peru) or social contextual circumstances (e.g., Operation Clean Up in Zimbabwe or the ‘War on Drugs’ in Thailand) served as learning opportunities because they generated substantial interaction among the research, the CAB, and the larger community. Importantly, in each case CABs were asked to address debatable issues affecting research. These interactions can be of mutual benefit when the value of the consultative process is improved in the eyes of both the researchers and CAB members leading to a more genuine partnership. As researchers come to understand how the CABs can contribute to the research process by addressing community concerns and respond to community needs, CABs can be a strategy through which the benefits of the research are made generally known and accepted within their communities. CABs can be dynamic entities, capable of evolving to meet critical and often surprising roles. The standing and status that the CABs themselves gain in this process give them visibility that can be useful both to researchers and communities. The presence of staff within the research structure assigned specifically to facilitate the work of http://ctj.sagepub.com

Building community and research partnerships the CAB appears to be important in fostering maturation, especially when those staff are skilled in community mobilization and communication techniques. Investment in these staff skills may be a critical component to build the partnerships essential to successful research. The community relations staff and CAB can complement each other’s efforts to strengthen the overall quality of the researchcommunity partnership. In our study, in fact, we found that it was the commitment and the joint effort of the research staff and the CAB members that allowed the research sites to navigate the critical incidents mentioned above, and strengthen, in the process, the work of the CABs. The National Institutes of Health have recognized that deploying these skills at the very outset to prepare communities for the issues may be important in avoiding potential problems in community acceptance. A conceptual and pragmatic distinction is often made between health care and health research. Yet, in less developed countries the dichotomy between research and care may instead be a continuum where research provides access to otherwise unavailable services. Ethical arguments for the protection of human participants form the basis for such a separation of research and care. However, how ethics is defined depends greatly on the cultural and situational frame of reference. Research at all three sites is conducted in addition to some form of social support service, such as clinical care or community mobilization. In some cases the changes in how the research engages with the community seems to have come about as a result of CAB feedback. A key aspect of community collaborative research is respecting community needs [11,12]. The blending of research and care observed in this study resulted from efforts to more completely address community priorities; research alone might be insufficient to do so. Questions of who is the community and who represents the community are frequently brought up in community collaborative research. Each site employed a broad community engagement model seeking involvement from a diverse cross section of society. Community is conceived of as more than the target populations of the research. Instead, it is conceptualized as people affected by the research and vulnerable populations more generally. Each site consulted with political leaders, public officials, and community leaders, individuals vested with greater authority to influence the research. Implicit in involving such segments in the community consultation process is recognition of how best to integrate research into the larger social context. A question for future empirical work would be to study CABs as dynamic entities in order to http://ctj.sagepub.com

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examine the processes by which more mature CABs go beyond formal expectations and take upon themselves other responsibilities and functions in order to better represent and advocate for their communities. Additional research on the use of community advisory groups is recommended in areas such as non-HIV health-related research, and the development and implementation of health services in developing countries, i.e., the implementation of HIV treatment and care.

Limitations This study has several limitations. Rapid Assessment as a data collection methodology is designed to capture a multi-perspective view of an event, system or process, based on the integration of multiple data sources, collected within a short period of time. The analysis process is an iterative examination of data by the researchers and is mostly carried out while in the field without a formal, systematic examination of transcribed and coded data. Case studies, as a method of examination, are meant to draw out what can be learned from a single case. Case studies are not, in the scientific sense, generalizable but have been used across disciplines of medicine, law and social science as a means of establishing precedence in seeking applications of the phenomena under examination. While it seems reasonable that a community consultation process would function similarly for non-HIV studies, the case study approach and the use of HIV research sites limits our ability to make such comments.

Conclusions This study suggests that community involvement can contribute to successful HIV/AIDS research in developing countries. Partnerships between researchers and community advisory groups appear to be strengthened when meaningful and debatable issues are brought to the consultation process. CABs or other community advisory groups have the potential to be brokers who bring community and research together. They can add to the standing and importance of research in the communities they serve, empower socially and politically weak populations, and serve as social agents that contribute to diminishing the secrecy and distrust associated with research and the stigma associated with HIV. Clinical Trials 2008; 5: 147–156

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Acknowledgments Funding for this study was provided by the HIV Prevention Trials Network (Family Health International Subagreement No. 645–39), which is funded through a grant from the National Institutes for Health (Cooperative Agreement No.: 1 U01AI46749). The authors thank the HPTN Community Working Group and particularly Janet Frohlich, D Cur, the International Co-Chair, for her assistance in shaping this study. We also appreciate the input and suggestions from the Family Health International Community Program Staff – Rhonda R. White, BS, RHEd, Stella Kirkendale, MPH, and Jeffrey Stanton, MPH. The authors also thank Community Advisory Board members, research staff, and clinical trial participants at sites of the HPTN that were part of this study. Note: The first author has served as Co-Chair of the HPTN Community Working Group and has been involved in oversight of the implementation of Community Advisory Boards. The UCSF field team (Morfit, Maiorana, & Richards) responsible for data collection in this study are not affiliated with HPTN. Views expressed in this article are those of the authors and may or may not reflect views of HPTN.

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